India: Overview Of The Drugs And Cosmetics (Tenth Amendment) Rules, 2018

Last Updated: 27 February 2019
Article by S.S. Rana & Co. Advocates


Drugs and Cosmetics Act, 1940 (hereinafter referred to as the 'Act') and Rules 1945 (hereinafter referred to as the 'Rules') were passed with the aim to ensure that only qualified personnel are engaged in manufacturing, importing, distribution and sale of drugs and cosmetics, confirming safe and effective drugs and cosmetics are being sold. It also prevents entry of substandard drugs and cosmetics in the Indian market. The Act and the Rules have been amended several times since coming into force to meet the need of the hour.


The latest amendments made in the Rules are for implementation of increase in application fees for grant of various import licenses, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations. These amendments have been brought vide the Drugs and Cosmetics (Tenth Amendment) Rules, 2018 w.e.f. October 12, 2018. The Ministry of Health and Family Welfare directed concerned officers in Central Drugs Standard Control Organization (CDSCO) (HQ) and its Zonal, Sub-zonal and Port offices to ensure implementation of the above amendment via office memorandum1 dated December 17, 2018.

Increase in import licence fee for drugs

The application fee for obtaining import licence by a person who has a valid wholesale licence for sale or distribution of drugs has increased from INR 1000 (USD 15 approx.) to INR 10,000 (USD 150 approx.) for single drug and additional fee has also been increased from INR 100 (USD 1.5 approx.) to INR 1000 (USD 15 approx.). Furthermore, fees for obtaining a duplicate copy of the said licence has been increased to INR 1500 (USD 22 approx.) as compared to earlier fees of INR 250 (USD 4 approx.).

Increase in fees for obtaining Registration Certificate

A person having a valid wholesale licence for sale or distribution of drugs now has to pay USD 10,000 and additional fee of USD 5000 for additional drugs as opposed to USD 1500 and USD 1000 for additional drug pre-amendment. Furthermore, payment of USD 25,000 has to be made towards inspection or visit of the manufacturing premises or drugs by the licensing authority. Additionally, USD 1800 or its equivalent in Indian rupees shall be paid for making amendment in the registration certificate or issuing duplicate certificate whereas the fees pre-amendment was USD 300.

Increase in fees for obtaining licence for examination, test or analysis

The application for obtaining licence for examination, test or analysis shall be accompanied by INR 5000 (USD 71 approx.) for a single drug and an additional fee of INR 2000 (USD 29 approx.). Earlier the fee was INR 100 (USD 1.5 approx.) for a single drug and an additional fee of INR 50 (USD 1 approx.).

Fees for obtaining licence for importing small quantities of new drug

Any Government Hospital or Autonomous Medical Institution who wishes to obtain licence for importing small quantities of new drug for treating its patients has to file an application along with INR 600 (USD 9 approx.) for a single drug and an additional fee of INR 300 (USD 5 approx.) as compared to the earlier fee of INR 100 (USD 1.5 approx.) for a single drug and an additional fee of INR 50 (USD 1 approx.).

Import or Manufacture of new drug for Clinical Trials or Marketing

The fees accompanied with application for grant of permission to import a new drug has been increased from INR 50,000 (USD 706 approx.) to INR 2,50,000 (USD 3526 approx.). Likewise, an application for permission to import or manufacture fixed dose combination of two or more drugs had to be earlier accompanied with INR 15,000 (USD 212 approx.). However, post-amendment the fee has been modified as INR 15000 (USD 212 approx.) in case of application for manufacture of the fixed dose combinations and INR 1,00,000 (USD 1412 approx.) in case of import application of the fixed dose combinations.

Import and Registration of Cosmetics

In order to obtain licence to import cosmetics, the concerned application has to be now accompanied by USD 2000 or its equivalent in Indian rupees for each brand of cosmetic and a fee of USD 50 for each variant, whereas earlier the fees was USD 250 for each brand irrespective of number of variants. Moreover, the fees for obtaining duplicate licence has been increased to USD 500 from USD 100.


The application fees for grant of various licences relating to import of drugs and cosmetics has been substantially increased. The Ministry of Health and Family Welfare has also taken due steps to ensure that these amendments are properly enforced. However, the effect of these amendments in the drugs and cosmetics sector is yet to be noticed.


1 Office Memorandum F. No. 18-68/2018-DC dated 17.12.2018 available at .

For further information please contact at S.S Rana & Co. email: or call at (+91- 11 4012 3000). Our website can be accessed at

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions